Clinical trial · Interventional

Genotype-guided Treatment in DLBCL

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

NCT05351346CI-TRIAL-00064971unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Diffuse Large B Cell Lymphoma	Diffuse Large B-Cell Lymphoma	CURATED_BROADER	0.80

Interventions

Interventions (8)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Decitabine	Drug	Decitabine	ALIAS
Doxorubicin	Drug	Doxorubicin	ALIAS
Lenalidomide	Drug	Lenalidomide	ALIAS
Orelabrutinib	Drug	—	UNRESOLVED
Prednisone	Drug	Prednisone	ALIAS
Rituximab	Drug	Rituximab	ALIAS
Vincristine	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
R-CHOP-X
description
Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle.
interventionNames
1. Drug: Rituximab
2. Drug: Cyclophosphamide
3. Drug: Doxorubicin
4. Drug: Vincristine
5. Drug: Prednisone
6. Drug: Orelabrutinib
7. Drug: Lenalidomide
8. Drug: Decitabine
type
ACTIVE_COMPARATOR
label
R-CHOP
description
Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
* Availability of archival or freshly collected tumor tissue before study enrolment
* International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy greater than or equal to (\>/=) 6 months
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research

Exclusion Criteria:

* Previous chemotherapy.
* Previous stem cell transplantation.
* History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Patients with central nervous system (CNS) lymphoma
* Primary mediastinal large B-cell lymphoma
* Left ventricular ejection fraction\<50%
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

  1. Neutrophils\<1.5×10\^9/L
  2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN.
* HIV-infected patients
* Positive test results for chronic hepatitis B and hepatitis C infection
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* Pregnant or lactation
* Require treatment with strong/moderate CYP3A inhibitors or inducers.
* Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
* Other medical conditions determined by the researchers that may affect the study

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment